TIDMAZN
RNS Number : 7284M
AstraZeneca PLC
25 January 2021
25 January 2021 07:00 GMT
Calquence met primary efficacy endpoint in head-to-head
trial
against ibrutinib in chronic lymphocytic leukaemia
Superior safety on key secondary endpoint of atrial
fibrillation
Positive high-level results from the ELEVATE-RR Phase III trial
showed AstraZeneca's Calquence (acalabrutinib) met the primary
endpoint demonstrating non-inferior progression-free survival (PFS)
for adults with previously treated, high-risk chronic lymphocytic
leukaemia (CLL) compared to ibrutinib.
The trial also met a key secondary endpoint for safety, showing
patients treated with Calquence had statistically significantly
lower incidence of atrial fibrillation compared to patients treated
with ibrutinib. Atrial fibrillation is an irregular heart rate that
can increase the risk of stroke, heart failure and other
heart-related complications . (1) Further hierarchical testing
revealed no difference for Grade 3 or higher infections or
Richter's transformation. There was a descriptive trend for
numerically favourable overall survival. Overall, the safety and
tolerability of Calquence were consistent with the profile seen in
the broader Calquence clinical development programme.
ELEVATE-RR is the first Phase III trial to compare two Bruton's
tyrosine kinase (BTK) inhibitors in patients with CLL, the most
common type of leukaemia in adults.(2) Patients diagnosed with
high-risk CLL may experience rapid worsening of their disease,
requiring treatment.(3)
José Baselga, Executive Vice President, Oncology R&D, said:
"With over forty months of follow-up, today's results confirm that
Calquence, a selective BTK inhibitor, displays superior safety in
atrial fibrillation without compromising efficacy. The totality of
the data confirm our confidence in the favourable benefit-risk
profile of Calquence."
The data will be presented at a forthcoming medical meeting and
shared with health authorities.
CLL
CLL is the most common type of leukaemia in adults, with an
estimated 114,000 new cases globally in 2017, and the number of
people living with CLL is expected to grow with improved treatment
as patients live longer with the disease.(2,4-6) In CLL, too many
blood stem cells in the bone marrow become abnormal lymphocytes and
these abnormal cells have difficulty fighting infections. As the
number of abnormal cells grows, there is less room for healthy
white blood cells, red blood cells, and platelets. This could
result in anaemia, infection, and bleeding.(4) B-cell receptor
signalling through BTK is one of the essential growth pathways for
CLL.
ELEVATE-RR
ELEVATE-RR (ACE-CL-006) is a randomised, multicentre, open-label
Phase III non-inferiority trial of Calquence versus ibrutinib in
patients with previously treated CLL with high-risk features
(presence of 17p deletion and/or 11q deletion). In the trial, 533
patients were randomised (1:1) into two arms. Patients in the first
arm received Calquence (100mg orally twice daily) until disease
progression or unacceptable toxicity. Patients in the second arm
received ibrutinib (420mg orally once daily) until disease
progression or unacceptable toxicity.(7)
The primary endpoint for the trial was PFS assessed by an
independent review committee (non-inferiority; tested after 250
events). Secondary endpoints included incidence of atrial
fibrillation, incidence of treatment-emergent Grade 3 or higher
infections, incidence of Richter's transformation (a condition in
which CLL changes into an aggressive form of lymphoma) and overall
survival.(7)
Calquence
Calquence (acalabrutinib) is a next-generation, selective
inhibitor of BTK. Calquence binds covalently to BTK, thereby
inhibiting its activity.(8,9) In B-cells, BTK signalling results in
activation of pathways necessary for B-cell proliferation,
trafficking, chemotaxis, and adhesion.(8)
Calquence is approved for the treatment of CLL and small
lymphocytic lymphoma in the US and approved for CLL in the EU and
several other countries worldwide. Calquence is under regulatory
review in Japan for relapsed or refractory CLL. A Phase I trial is
currently underway in Japan for the treatment of 1st-line CLL.
In the US and several other countries, Calquence is also
approved for the treatment of adult patients with mantle cell
lymphoma (MCL) who have received at least one prior therapy. The US
MCL indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in confirmatory trials. Calquence is not currently approved for the
treatment of MCL in Europe or Japan.
As part of an extensive clinical development programme,
AstraZeneca and Acerta Pharma are currently evaluating Calquence in
more than 20 company-sponsored clinical trials. Calquence is being
developed for the treatment of multiple B-cell blood cancers
including CLL, MCL, diffuse large B-cell lymphoma, Waldenström's
macroglobulinaemia, follicular lymphoma, and other haematologic
malignancies.
AstraZeneca in haematology
Leveraging its strength in oncology, AstraZeneca has established
haematology as one of four key oncology disease areas of focus. The
Company's haematology franchise includes two medicines approved in
the US and a robust global development programme for a broad
portfolio of potential blood cancer treatments. Acerta Pharma
serves as AstraZeneca's haematology research and development arm.
AstraZeneca partners with like-minded science-led companies to
advance the discovery and development of therapies to address unmet
need.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With seven
new medicines launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- and by championing the development of personalised combinations,
AstraZeneca has the vision to redefine cancer treatment and one day
eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca .
Contacts
For details on how to contact the Investor Relations Team,
please click here. For Media contacts, click here .
References
1. Mayo Clinic. Patient Care & Health Information, Diseases
& Conditions - Atrial Fibrillation.
Available at:
https://www.mayoclinic.org/diseases-conditions/atrial-fibrillation/symptoms-causes/.
Accessed January 2021.
2. American Cancer Society. What is Chronic Lymphocytic
Leukemia. Available at:
https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html
. Accessed January 2021.
3. Cancer.net. Leukemia-Chronic Lymphocytic - CLL: Stages.
Available at:
https://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/stages
. Accessed January 2021.
4. National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ(R) )-Patient Version. Available at:
https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq .
Accessed January 2021.
5. Global Burden of Disease Cancer Collaboration. Global,
Regional, and National Cancer Incidence, Mortality, Years of Life
Lost, Years Lived With Disability, and Disability-Adjusted
Life-Years for 29 Cancer Groups, 1990 to 2017. JAMA Oncol.
2019;5(12):1749-1768.
6. Jain N, et al. Prevalence and Economic Burden of Chronic
Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies.
Blood. 2015;126:871. 5.
7. Clinicaltrials.gov. NCT02477696. Accessed September 18, 2020.
Study started in October 2015.
8. CALQUENCE (acalabrutinib) [U.S. prescribing information].
Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.
9. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a
selective second-generation BTK inhibitor. J Hematol Oncol.
2016;9(21).
Adrian Kemp
Company Secretary
AstraZeneca PLC
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